Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000835943
Ethics application status
Approved
Date submitted
7/08/2011
Date registered
9/08/2011
Date last updated
13/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined neoadjuvant chemotherapy docetaxel (Taxotere), cisplatin and 5-Fluorouracil and concurrent chemoradiation in treating patients with locally advanced nasopharyngeal carcinoma
Scientific title
The efficacy and safety of combined neoadjuvant chemotherapy with docetaxel, cisplatin and 5-Fluorouracil (5-FU) [TPF regimen] and concurrent chemoradiation in treating patients with locally advanced nasopharyngeal carcinoma
Secondary ID [1] 262794 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal carcinoma 270500 0
Condition category
Condition code
Cancer 270660 270660 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
single arm phase II study evaluating the efficacy and safety of the combined neoadjuvant chemotherapy with intravenous docetaxel (Taxotere), cisplatin and 5-Fluorouracil (5-FU) [TPF regimen; T: Taxotere, P: Cisplatin F: 5-FU] and concurrent chemoradiation with weekly intravenous cisplatin in patients with locally advanced nasopharyngeal carcinoma.
Fifty eligible patients with pathologically proven locally advanced nasopharyngeal carcinoma are enrolled.
Neoadjuvant chemotherapy: Patients initially receive neoadjuvant chemotherapy comprising intravenous docetaxel (75 mg/m2) and intravenous cisplatin (100 mg/m2) on day 1 and intravenous 5-FU (750 mg/m2) continuously on days 1-3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses of neoadjuvant chemotherapy, all Patients proceed to chemoradiotherapy.
Chemoradiotherapy: 3 weeks after completion of neoadjuvant chemotherapy, patients undergo 7 weeks concurrent chemoradiation with weekly intravenous cisplatin (40 mg/m2).
Intervention code [1] 269141 0
Treatment: Drugs
Comparator / control treatment
This is single arm phase II study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269379 0
Clinical response rates determined based on the direct laryngoscopic and physical examination and imaging [(Computed Tomography (CT) scan] findings
Timepoint [1] 269379 0
Direct nasopharyngoscopic and physical examination and imaging (CT scan) will be performed 3 weeks after the last (3rd) cycle of neoadjuvant chemotherapy and 4 weeks following completion of chemoradiation.
Secondary outcome [1] 287516 0
Acute treatment-related toxicities will be measured by clinician assessment and graded according to theWHO common toxicity criteria.
Timepoint [1] 287516 0
Acute treatment-related toxicites [such as hematologic (leukopenia, anemia, thrombocytopenia), gastrointestinal (diarrhea, vomiting), neurological (neuropathy, pain, hand foot syndrome) toxicities] will be assessed at baseline, at the end of every sequential neoadjuvant chemotherapy cycle and weekly during concurrent chemoradiotherapy.

Eligibility
Key inclusion criteria
1. Pathologically proven nasopharyngeal carcinoma.
2. No prior therapy
3. No clinical or imaging evidence of distant metastasis at the time of study enrollment
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Written informed consent
6. Normal or acceptable liver, kidney and bone marrow function (Absolute neutrophil count greater than or equal to 1,500/mm3
Platelet count greater than or equal to 100,000/mm3
Bilirubin < 1.5 times the upper limit of the normal range
Alkaline phosphatase and transaminases < 2.5 times the upper limit of the normal range
Serum creatinine < 1.7 mg/dL)
Females must not be pregnant or lactating
Minimum age
15 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior therapy 2. Clinical or imaging evidence of distant metastasis 3. Patients with a known contraindication (such as allergy to taxan drugs,
5. Patients must have
normal cardiac function [Left ventricular ejection fraction (LVEF) assessed by Multigated radionuclide angiography (MUGA) or echocardiography (ECHO) and clinically satisfactory 12-lead electrocardiography (ECG)
No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
History of documented congestive heart failure
High-risk uncontrolled arrhythmias
Angina pectoris requiring antianginal medication
Clinically significant valvular heart disease
Evidence of transmural infarction on ECG
Poorly controlled hypertension (e.g., systolic blood presure (BP) > 180 mm Hg or diastolic BP > 100 mm Hg)]
6. Patients with severe liver, renal, inflammatory intestinal or blood coagulation disorders,

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3773 0
Iran, Islamic Republic Of
State/province [1] 3773 0

Funding & Sponsors
Funding source category [1] 269616 0
University
Name [1] 269616 0
Shiraz University of Medical Sciences
Country [1] 269616 0
Iran, Islamic Republic Of
Primary sponsor type
Government body
Name
Shiraz University of Medical Sciences
Address
Shiraz University of Medical Sciences, Shiraz 71936-13511, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 266648 0
None
Name [1] 266648 0
Address [1] 266648 0
Country [1] 266648 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Nasopharyngeal carcinoma (NPC) is a special entity in which the location does not lend itself to curative surgery. NPC is highly radiosensitive, and radical external beam radiotherapy is the mainstay of treatment for this neoplasm and its regional lymph node metastasis. Concurrent cisplatin-based chemoradiation with neoadjuvant or sequential adjuvant chemotherapy is currently the standard care for locoregionally advanced nasopharyngeal carcinoma. Patients with NPC tend to have advanced disease at the time of presentation. Locoregional and systemic failures are high in these patients and contribute to the poor survival. More effective chemotherapeutic regimens and other systemic therapy are needed to decrease the rate of locoregional and distant failure and improve survival. Neoadjuvant chemotherapy followed by concurrent chemoradiation is an alternative choice for these patients. The current clinical trial aimed to investigate the efficacy and safety of neoadjuvant chemotherapy by TPF regimen followed by concurrent chemoradiation with weekly cisplatin in this regard.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32987 0
Address 32987 0
Country 32987 0
Phone 32987 0
Fax 32987 0
Email 32987 0
Contact person for public queries
Name 16234 0
Mohammad Mohammadianpanah
Address 16234 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 16234 0
Iran, Islamic Republic Of
Phone 16234 0
0098 711 6125170
Fax 16234 0
0098 711 6474320
Email 16234 0
[email protected] ; [email protected]
Contact person for scientific queries
Name 7162 0
Mohammad Mohammadianpanah
Address 7162 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 7162 0
Iran, Islamic Republic Of
Phone 7162 0
0098 711 6125170
Fax 7162 0
0098 711 6474320
Email 7162 0
[email protected] ; [email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe efficacy and safety of induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in treating patients with locally advanced nasopharyngeal carcinoma2012https://doi.org/10.1016/j.ejenta.2012.10.004
N.B. These documents automatically identified may not have been verified by the study sponsor.